Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine HydrochlorideEVIPLERA
Treatment of human immunodeficiency virus (HIV) infection in treatment-naïve adult patients and as continuing treatment in patients who have previously received PBS-subsidised therapy for HIV infection.
Access path
- TGA registered · EVIPLERA
TGA label narrower than the PBS population
- Nov 2011Recommended · restricted
Comparator changed: Atripla (tenofovir disoproxil fumarate with emtricitabine and…
- Nov 2011Recommended · restricted
Comparator changed: Atripla (tenofovir disoproxil fumarate with emtricitabine and…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC recommended listing of tenofovir disoproxil fumarate with emtricitabine and rilpivirine hydrochloride (Eviplera®) in the Section 100 Highly Specialised Drugs (HSD) Program for the treatment of human immunodeficiency virus (HIV) infection on a cost-minimisation basis compared with the Atripla® (tenofovir disoproxil fumarate with emtricitabine and efavirenz). PBAC · 2011
Decision context
PopulationTreatment-naïve adult patients with HIV-1 infection; continuing treatment in patients who have previously received PBS-subsidised therapy for HIV infection, including those with CD4 count less than 500 per cubic millimetre or symptomatic HIV disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2011 | Recommended · restricted | Atripla (tenofovir disoproxil fumarate with emtricitabine and efavirenz) | — | RCT · virologic response (plasma viral load < 50 HIV-1 RNA copies/mL) at 48 weeks |
| Nov 2011 | Recommended · restricted | tenofovir disoproxil fumarate with emtricitabine and efavirenz (Atripla) | — | RCT · Viral load <50 copies/mL |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CD4 <500 or symptomatic disease; TGA label requires only HIV RNA ≤100,000 copies/mL without CD4 threshold.